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Hemodynamic Effects of Rolofylline in the Treatment of Patients With Heart Failure (7418-503)

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ClinicalTrials.gov Identifier: NCT00729222
Recruitment Status : Completed
First Posted : August 7, 2008
Last Update Posted : October 20, 2015
Sponsor:
Collaborator:
NovaCardia, Inc.
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.

Brief Summary:
The study will estimate the effects of rolofylline, alone and in addition to loop diuretic therapy on pulmonary capillary wedge pressure and other hemodynamic parameters, in patients with heart failure and renal impairment.

Condition or disease Intervention/treatment Phase
Heart Failure Drug: Comparator: Placebo Drug: rolofylline Phase 2

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: A Multicenter, Randomized, Double-blind, Placebo-controlled Study of the Hemodynamic Effects of Rolofylline Injectable Emulsion in the Treatment of Patients With Heart Failure
Study Start Date : November 2008
Actual Primary Completion Date : March 2009
Actual Study Completion Date : March 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Failure
U.S. FDA Resources

Arm Intervention/treatment
Placebo Comparator: 1
Placebo
Drug: Comparator: Placebo
rolofylline placebo IV infusion over 4 hours.
Experimental: 2
rolofylline
Drug: rolofylline
rolofylline 30 mg IV infusion over 4 hours.



Primary Outcome Measures :
  1. change in pulmonary capillary wedge pressure [ Time Frame: from baseline to 4 and 8 hours ]

Secondary Outcome Measures :
  1. Change in cardiac output, systemic vascular resistance, pulmonary vascular resistance, pulmonary pressure and right atrial pressure [ Time Frame: from baseline to 4 and 8 hours ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients with heart failure and renal impairment, currently using furosemide, with systolic blood pressure >95 mm Hg

Exclusion Criteria:

  • Patient has active infection, use of diuretic within 3 hours of screening visit, has acute tubular necrosis or severe pulmonary disease, any heart problems within the last two weeks

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00729222


Sponsors and Collaborators
Merck Sharp & Dohme Corp.
NovaCardia, Inc.
Investigators
Study Director: Medical Monitor Merck Sharp & Dohme Corp.

Publications of Results:
Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT00729222     History of Changes
Other Study ID Numbers: 7418-503
MK7418-503
2008_532
First Posted: August 7, 2008    Key Record Dates
Last Update Posted: October 20, 2015
Last Verified: October 2015

Additional relevant MeSH terms:
Heart Failure
Heart Diseases
Cardiovascular Diseases
Rolofylline
Diuretics
Natriuretic Agents
Physiological Effects of Drugs